Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks (SaMi2)

Boston University

Status and phase: Completed; Phase 3

Conditions: Cervical Preparation

Treatments: Drug: Mifepristone; Device: osmotic dilators

Study type: Interventional

Funder types: Other

Identifiers

NCT01436279

H-31032

AU 6003109 (Other Grant/Funding Number)

Details and patient eligibility

About

In this study the investigators plan to compare mifepristone and misoprostol use to osmotic dilator use for cervical preparation for 15-18 week surgical abortion. Mifepristone would be given 24 hours prior to abortion, and misoprostol 400 mcg would be administered buccally 2 hours prior to abortion. Osmotic dilators are the method currently used in our institution, and are placed 24 hours prior to abortion. The primary outcome will be the length of the procedure. Secondary outcomes will include amount of dilation achieved, ease of procedure, participant's assessment of discomfort before mifepristone or dilators, discomfort during the abortion procedure, acceptability to participants, and acceptability to staff.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women 18-50 years of age undergoing surgical termination of pregnancy
• English or Spanish speaking
• Gestational age between 15 and 18 weeks gestation on day of abortion (inclusive), by ultrasound dating
• Eligible for a dilation and evacuation abortion with local anesthesia and sedation
• Ultrasound for dating purposes done within the last two weeks

Exclusion criteria

• Intrauterine infection
• Fetal demise
• Ruptured membranes
• Multiple gestation
• Uterine anomaly or significant distortion of the uterus with fibroids
• BMI greater than 45
• Inability to place osmotic dilators
• Active substance abuse or intoxication
• Adrenal failure, chronic corticosteroid use, anticoagulant usage
• Severe cervicitis, until treated and resolved
• Prior Cesarean section

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Mifepristone + misoprostol

Experimental group

Description:

Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure

Treatment:

Drug: Mifepristone

Osmotic dilators

Active Comparator group

Description:

Placed 20-24 hours prior to procedure

Treatment:

Device: osmotic dilators